MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418164730
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00202 (b)(4).Concomitant medical products: unknown micro catheter, y connector (okay, goodman), enpower control cable.The presidio coil will not be returned; therefore the root cause of the coils non-detachment cannot be determined.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a health care professional, during the coil embolization of an aneurysm at the left internal iliac artery a presidio cere coil (pc418164730/c41367) failed to detach.Patient was a (b)(6) male whose vessels were mildly torturous and mildly calcified.The pre-insertion electrical check was successful and the coil was placed without any problem.However when the detach button was pressed, the detachment light did not illuminate and the coil did not detach.The coil was replaced with a new one (different lot#).The procedure was successfully completed without further issues or delay.The same connecting cable and detachment control box were used with coils prior to and after the event.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.The product is not available for the investigation.No further information is available.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5945659
• Report Number: 2954740-2016-00202
• Device Sequence Number: 13854040
• Product Code: HCG
• UDI-Device Identifier: 00878528003281
• UDI-Public: (01)00878528003281(17)210228(10)C41367
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: PC418164730
• Device Lot Number: C41367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2016
• Initial Report FDA Received Date: 09/13/2016
• Patient Sequence Number: 1
• Patient Age: 78 YR